Upcoming Training Sessions

Good Clinical Practice or ‘GCP’ training for investigators and study-team members is increasing becoming required by institutions, sponsors, and the NIH. This 90 minute course will explain the elements of the International Conference for Harmonization’s (ICH) principles and specific guidelines for Good Clinical Practice. Attendees will be introduced to the GCP Principles, and will explore investigator responsibilities in human subject research, focusing on the areas of trial conduct (experience, resources, and physician duties); performance (communication with the IRB, protocol compliance, and investigational product management); ethical research (safety oversight and informed consent); and recording/reporting (data acquisition, progress summaries, and safety-event reporting).. Please register via this link: http://lms14.learnshare.com/l.aspx?CID=89&A=2&T=339728

Session dates/times:

Classes are held the 4th Friday of each month (10:00 a.m. - 11:30 a.m.)

Training Sessions: NIH's Single Review Requirement (JHM IRB)

As of January 2018*, all competing National Institutes of Health (NIH) grant applications for multi-site research require a plan for use of a single IRB. Johns Hopkins is building capacity to serve as a single/central IRB, but there are also cases where Johns Hopkins will be asked to rely on an external IRB. This training will review website tools and instructions available to support requests to rely on an external IRB; provide guidance about the local institutional review required when JH relies on an external IRB [both initial and ongoing]; and review the roles and responsibilities of local site PIs and study teams when relying on an external IRB. Investigators and study team members submitting external IRB applications subject to these new requirements are encouraged to attend.. Please register via this link: http://lms14.learnshare.com/l.aspx?CID=89&A=2&T=698882

Session dates/times:

Tuesday 3/6/18 from 11am - 12pmPhipps Room 140

Tuesday 4/12/18 from 1pm - 2pmPhipps Room 240

Training Sessions: Relying on An External IRB (JHM IRB)

As of January 2018*, all competing National Institutes of Health (NIH) grant applications for multi-site research require a plan for use of a single IRB. Johns Hopkins is building capacity to serve as a single/central IRB, but there are also cases where Johns Hopkins will be asked to rely on an external IRB. This training will review website tools and instructions available to support requests to rely on an external IRB; provide guidance about the local institutional review required when JH relies on an external IRB [both initial and ongoing]; and review the roles and responsibilities of local site PIs and study teams when relying on an external IRB. Investigators and study team members submitting external IRB applications subject to these new requirements are encouraged to attend.. Please register via this link:http://lms14.learnshare.com/l.aspx?CID=89&A=2&T=723315

Session dates/times:

Check back for future dated sessions/times

*January 25, 2018 is the currently proposed implementation deadline for NIH's Policy on single IRB review.